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510(k) Data Aggregation
(20 days)
DRAGER, INC.
The Evita 2 dura and the Evita 4 are time cycled , constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg.
Intended environment for use of the device
- user facilities ..
- inner clinical transport -
The Evita 4 or the Evita 2 dura are time cycled microprocessor-controlled intensive care ventilators. Both devices can be equipped with the ATC option. ATC means automatic tube compensation. This ventilation mode extension provides a compensation of an endotracheal or tracheostomy tube. It calculates and displays the tracheal pressure from a mathematical model on the basis of selected type of tube and tube internal diameter.
The provided document is a 510(k) summary for the Dräger ATC option for Evita 2 dura and Evita 4 ventilators. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a standalone study with performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC studies, standalone performance), or ground truth establishment.
Instead, the document focuses on comparing the new device to predicate devices based on:
- Intended Use: Identical to predicate devices.
- Patient Range: Identical to predicate devices.
- Intended Environment for Use: Identical to predicate devices.
- Technology, Performance Specifications, Materials, Dimensions, Operating Parameters: Deemed substantially equivalent to predicate devices.
The FDA's letter (K992608) confirms the finding of "substantial equivalence" based on this comparison. It does not refer to a specific performance study against defined acceptance criteria.
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(30 days)
DRAGER, INC.
The Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL. With applications in: mobile emergency and primary care of emergency patients, patient transports in emergency rescue vehicles or by helicopter, patient transfers by road or air, inner hospital transport of ventilated patients, emergency room, secondary transports between hospitals.
The device is a software controlled and time cycled transport and emergency ventilator. It can be equipped with an external power supply for stationary operation in hospitals and is equipped with a NiCd Battery Pack for the during transport. The Oxylog 2000 has 5 rotary knobs for the adjustment of the ventilator rate, tidal volume, I:E ratio, inspiratory pressure limitation and peep.
The provided text describes a Special 510(k) submission for the Oxylog 2000 SW 3.n ventilator. It does not contain information about a study proving the device meets specific acceptance criteria in the way typically seen for AI/ML-enabled devices involving performance metrics like sensitivity, specificity, or F1-score.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device through a software change, asserting that "no questions regarding safety and effectiveness arose." The "study" mentioned is a laboratory test to show functional equivalence, not a statistical performance study against predefined metrics.
Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to the evaluation of AI/ML diagnostic or prognostic devices, which this ventilator is not.
Here's an attempt to extract and interpret the requested information based on the provided text, with explicit notes where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the submission) |
|---|---|
| Maintain intended use of predicate device | "exactly the same intended use like the predicate device" |
| Software change conforms to design control procedures | "carried out in accordance with Dräger's internal design control procedure and no questions regarding safety and effectiveness arose" |
| Technology for additional monitoring/ventilation mode is same as predecessor | "The technology...is the same as already used with the predecessor." |
| Control mechanism, energy type, materials are same as predecessor | "The control mechanism, the energy type and the materials used are exactly the same." |
| Breathing modes and possibilities are substantially equivalent to predecessor | "It was shown in laboratory tests that the breathing modes and the possibilities of the breathing modes are substantial equivalent." |
| Monitoring and alarm functions are comparable to predecessor | "The monitoring and alarm functions...are also comparable...There were no elementary deviation between the different possibilities..." |
| Device fulfills the same standards as the predecessor | "The device fulfils the same standards as the predecessor." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not specified. The "laboratory tests" mentioned are functional tests, not a statistical study on a patient-based test set.
- Data Provenance: Not applicable. The nature of the "tests" implies internal validation against functional specifications rather than data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for functional equivalence of a ventilator is typically established through engineering specifications, standards, and functional testing by qualified engineers and technicians, not through expert clinical consensus in the way a diagnostic AI would be evaluated.
4. Adjudication method for the test set
- Not applicable. This device's evaluation did not involve human-interpreted outputs requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a ventilator, not an AI-assisted diagnostic device. An MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of AI/ML. The device itself operates in a "standalone" fashion (as a ventilator), and its software changes were validated as part of its integral function.
7. The type of ground truth used
- Ground Truth: Functional specifications, engineering standards, and the performance characteristics of the predicate device. The "laboratory tests" would have validated the software's ability to maintain these specified operational parameters (e.g., ventilator rate, tidal volume, I:E ratio, inspiratory pressure limitation, PEEP, as well as monitoring and alarm functions).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that undergoes "training" on a dataset in the conventional sense. The software, while controlling the device, is likely based on deterministic control logic and algorithms developed through engineering principles, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable. No "training set" in the context of AI/ML.
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(84 days)
DRAGER, INC.
NeoFlow - Neonatal mode with base flow.
The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg.
The device is microprocessor controlled and provides the following ventilation modes:
- CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume constant ventilation, with the options: - CPPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
- SIMV Synchronised Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
- SB Spontaneous Breathing Spontaneous breathing at ambient pressure
- CPAP Continuos Positive Airway Pressure Spontaneous breathing with positive airway pressure
- ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
- PCV+ Pressure controlled ventilation, combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
- Apnea Ventilation For switching over automatically to volume controlled ventilation if breathing stops.
- ILV Independent Lung Ventilation Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each lung.
The Evita 4 NeoFlow option extends the patient range of the Evita 4 ventilator to neonates with a minimum weight of 0,5 kg.
The Evita 4 equipped with the NeoFlow option provides the following ventilation modes.
- CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume contant ventilation with the options: - CPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
- SB Spontaneous Breathing Spontaneous breathing at ambient pressure
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure
- ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
- PCV+ Pressure Controlled Ventilation Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable
- Apnea Ventilation For switching over automatically to volume controlled mandatory ventilation if breathing stops
- ILV Independent Lung Ventilation Separate, differentiated, synchronized ventilation with one Evita 4 for each lung.
Here's an analysis of the provided text regarding the Dräger Evita 4 NeoFlow Ventilator, focusing on acceptance criteria and study information.
Based on the provided document, there is no information about specific acceptance criteria or a study designed to prove the device meets those criteria.
The document is a 510(k) summary for the Dräger Evita 4 NeoFlow Ventilator, and its primary purpose is to demonstrate substantial equivalence to previously marketed devices, not to present performance data against specific acceptance criteria.
Therefore, many of the requested fields cannot be answered using the provided text.
However, I can extract and state what information is present:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not specified in the provided document.
- Reported Device Performance: Not detailed in the provided document in the context of specific performance metrics or acceptance criteria. The document describes the functionality of the device's NeoFlow option, which extends the patient range of the Evita 4 ventilator to neonates with a minimum weight of 0.5 kg and lists available ventilation modes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned. No specific test set or study data is presented.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. No ground truth establishment for a test set is discussed.
4. Adjudication Method for the Test Set
- Not applicable. No test set or adjudication method is discussed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No mention of an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a ventilator, not an AI algorithm.
7. Type of Ground Truth Used
- Not applicable. No study involving ground truth for performance evaluation is described.
8. Sample Size for the Training Set
- Not applicable. This document is a 510(k) for a medical device (ventilator), not an AI/ML device that typically involves training sets.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is relevant to this type of device submission as described.
Summary of Information from the Document:
The document describes the Dräger Evita 4 NeoFlow Ventilator, an option that extends the Evita 4 ventilator to neonates with a minimum weight of 0.5 kg. It lists the various ventilation modes the device offers. The 510(k) submission (K983219) was cleared by the FDA on December 7, 1998, based on substantial equivalence to predicate devices like the Evita 4, Babylog 8000 plus (both Dräger), and Servo 300 (Siemens). The FDA letter confirms the device is classified as Class II and is subject to general controls.
Key takeaway: This 510(k) summary focuses on the technical description and the claim of substantial equivalence for a hardware medical device (ventilator), not on a performance study against specific acceptance criteria using a test set which is more common for software or AI/ML components.
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(80 days)
DRAGER, INC.
Air compressor supplying compressed air for medical ventilators.
The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.
This K982789 submission is for a Medical Air Compressor "Model 98", not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The submission focuses on establishing substantial equivalence to a legally marketed predicate device, the Dräger Medical Air Compressor (K951126), through a comparison of specifications and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Medical Air Compressor Model 98" were based on demonstrating substantial equivalence to its predicate device, the "Medical Air Compressor (K 951126)". The reported performance for the new device matches the criteria set by the predicate.
| Specification | Acceptance Criteria (from Predicate Device K951126) | Reported Device Performance (Medical Air Compressor Model 98) |
|---|---|---|
| Intended Use | Air compressor supplying compressed air for medical respirators | Air compressor supplying compressed air for medical respirators |
| Safety: | ||
| High temperature alarm? | Yes | Yes |
| Audible alarm? | Yes | Yes |
| Visible alarm? | Yes | Yes |
| Main Fuses? | Yes | Yes |
| Performance Characteristics: | ||
| Dew point depression: below room temperature? | Yes | Yes |
| Air quality: Dust and oil free? | Yes | Yes |
| Installed filter? | Yes | Yes |
| Standby-Mode? | Yes | Yes |
| Operating Characteristics | Substantially equivalent to predicate | All operating characteristics of both devices are substantially equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a conventional medical device without AI/ML components. The evaluation method relies on direct comparison of specifications and functionality rather than data-driven performance metrics on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a conventional medical device. Ground truth as typically defined for AI/ML devices is not relevant here. The evaluation is based on engineering specifications and adherence to existing medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a conventional medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this conventional device, the "ground truth" for demonstrating substantial equivalence is the established specifications, performance characteristics, and safety features of the predicate device (Dräger Medical Air Compressor K951126), as well as relevant medical device standards. The "Model 98" is deemed acceptable if it meets or matches these established benchmarks.
8. The sample size for the training set
Not applicable. This is a conventional medical device.
9. How the ground truth for the training set was established
Not applicable. This is a conventional medical device.
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(197 days)
DRAGER, INC.
Evita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg.
Intended Environment for the device:
- hospital use
- inner clinical transport
The Evita 4 with the Software version 3.0 is a time cycled, constant volume ventilator The Evita + with the Oct.ware is microprocessor controlled and provides the following ventilation modes:
- CMV/assist
- SIMV
- MMV
- SB
- CPAP
- ASB/PSV
- PCV+
- APRV
- Apnea Ventilation
- ILV
This is a regulatory submission for a medical device (ventilator) and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical study report or a 510(k) submission for a diagnostic AI/ML device.
The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific clinical acceptance criteria through a dedicated study with experts establishing ground truth.
Therefore, many of the requested fields cannot be extracted directly from this document. I will fill in what can be inferred or stated as "Not applicable/Provided" based on the content.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner as one would expect for a diagnostic device. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "performance" is implicitly deemed acceptable if it is equivalent to the legally marketed predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Classification: Intensive Care Ventilator | Yes |
| Operating Principle: Time cycled, volume constant, pressure controlled | Yes |
| Software controlled | Yes |
| Gas delivery system: Fast "High Pressure Servo Valve", microprocessor controlled | Yes |
| Intended Use: For adults and children with body weight >= 3 kg | Identical to predicate Evita 4 (K 961687) |
| Modes of Ventilation | Identical to predicate Evita 4 (K 961687) |
| Ventilator Settings | Identical to predicate Evita 4 (K 961687) |
| Flow Trigger Sensitivity | Identical to predicate Evita 4 (K 961687) |
| Parameter setting | Identical to predicate Evita 4 (K 961687) |
| Monitors/Indicators | Identical to predicate Evita 4 (K 961687) |
| Pressure Limitation | Identical to predicate Evita 4 (K 961687) |
| Alarm Functions | Identical to predicate Evita 4 (K 961687) |
| Displayed Values | Identical to predicate Evita 4 (K 961687) |
| Displayed Curves | Identical to predicate Evita 4 (K 961687) |
| Intermittent PEEP | Identical with Evita 2 dura (K 970165) |
| Inspiration Hold | Identical with Evita 2 dura (K 970165) |
| Apnea Ventilation | Identical with Evita 2 dura (K 970165) |
| Nebulization | Identical with Evita 2 dura (K 970165) |
| Nebulization in pediatric mode | Identical with Evita 2 dura (K 970165) |
| Suction Help Mode | Identical with Evita 2 dura (K 970165) |
| Switch over function | Identical with Evita 2 dura (K 970165) |
| Leak-Compensation | Identical with Evita 2 dura (K 970165) |
| Minute Volume-Leak | Identical with Evita 4 (K 961687) |
| Overall Safety and Efficiency | Substantially equivalent to predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Provided. This document does not describe a clinical study with a "test set" in the context of diagnostic performance evaluation. The substantial equivalence claim is based on comparing technical specifications and intended use.
- Data Provenance: Not applicable/Provided. No specific "data" in terms of patient results is discussed. The device is manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany, and sold in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/Provided. This document does not pertain to an AI/ML diagnostic device requiring expert-established ground truth.
- Qualifications of experts: Not applicable/Provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No. This is a ventilator, not an AI-assisted diagnostic device for human readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable in the context of an AI/ML algorithm. This device is a ventilator, designed to be used by trained medical professionals. Its "performance" refers to its mechanical and software functions meeting specifications, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable in the traditional sense of diagnostic device evaluation. The "ground truth" for a ventilator's performance would be its adherence to established electrical, mechanical, and software specifications, and its ability to safely and effectively deliver ventilation as intended, as demonstrated through engineering tests and comparison to legally marketed predicate devices.
8. The sample size for the training set
- Sample size for training set: Not applicable/Provided. This document does not describe an AI/ML device that undergoes training on a dataset.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/Provided.
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(223 days)
DRAGER, INC.
The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 lbs).
The device provides the following ventilation modes:
CMV Continuous Mandatory Ventilation
AIC Assist Control Ventilation
SIMV Synchronized Intermittent Mandatory Ventilation
Pressure Support Ventilation (available option) PSV
CPAP Continuous Positive Airway Pressure
Ventilation mode extension:
VG Volume Guarantee (available option), Volume controlled ventilation
VIVE Variable Inspiratory, Variable Expiratory Flow
The Babylog 8000 plus is an enhanced version of its predecessor Babylog 8000. It is a long-term, microprocessor-controlled, intensive care ventilator for premature and newborn babies, as well as for infants weighing up to about 10 kg.
The Babylog 8000 plus ventilates according to the continuous-flow principle with either time control or volume control, depending on the ventilation mode, and pressure limitation. Oxygen is metered out by the integrated air/O2 mixer.
A variety of the device functions are monitored in operation to make sure that safety-relevant failures are detected and safety for the patient is maintained.
The analog and digital interface is optionally available for connecting the Babylog 8000 plus to a device like a patient monitor or computer so that measured values and settings can be transferred to such equipment.
The ventilator can also be combined with a medicament nebulizer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dräger Babylog 8000 plus ventilator.
The document is a 510(k) Summary of Safety and Effectiveness for the Dräger Babylog 8000 plus. It focuses on demonstrating substantial equivalence to predicate devices (Babylog 8000 and Servo 300), rather than outlining specific, quantitative 'acceptance criteria' in the typical sense of a clinical trial or performance study with numerical thresholds and associated statistical proof.
Instead, the "acceptance criteria" here are implicitly defined by the characteristics of the predicate devices. The study's aim is to show the new device meets or exceeds the safety and effectiveness of these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit numerical acceptance criteria are not presented in a traditional "pass/fail" format. The "acceptance criteria" are the functional specifications and performance characteristics of the legally marketed predicate devices (Babylog 8000 and Siemens Servo 300). The "reported device performance" is the claim of substantial equivalence for the Babylog 8000 plus to these characteristics.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Babylog 8000 plus) |
|---|---|---|
| Ventilator Type | Intensive Care Ventilator (21 CFR 868.5895) | Intensive Care Ventilator (21 CFR 868.5895) |
| Intended Use | Long-term ventilation for premature/newborn babies and infants up to 10 kg. | Long-term ventilation for premature/newborn babies and infants up to 10 kg (22lbs). |
| Control Principle | Servo 300: pressure-controlled or volume-controlled, time-cycled or flow-cycled, pressure-limited. | |
| Babylog 8000: time-controlled, time-cycled, pressure-limited. | Time-controlled or volume-controlled; time-cycled or flow-cycled; pressure-limited. (Claimed substantially equivalent to Servo 300 where enhanced). | |
| Software controlled | Yes (both predicates) | Yes |
| Ventilation modes: | ||
| CPAP | Yes (both predicates) | Yes |
| CMV | Yes (both predicates) | Yes |
| Assist Control | Yes (both predicates) | Yes (AIC Assist Control Ventilation - time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation, synchronized with each spontaneous patient breath) |
| SIMV | Yes (both predicates) | Yes (Synchronized Intermittent Mandatory Ventilation - time-controlled, volume triggered, flow cycled, pressure-limited continuous flow ventilation, synchronized with patient's spontaneous breathing at the set ventilation rate) |
| PSV | Yes (Servo 300), No (Babylog 8000) | Substantially equivalent to Servo 300. (Pressure Support Ventilation - Time-controlled, volume triggered, flow cycled, pressure-limited ventilation synchronized with each spontaneous patient breath). |
| VG (Volume Guarantee) | No (both predicates) | Available option. Volume controlled ventilation. Ventilator controls inspiratory pressure to deliver preset tidal volume. May be combined with AIC, SIMV and PSV. (This is an enhancement, not a direct equivalence). |
| VIVE (Variable Insp. Exp. Flow) | No (both predicates) | Available option. Separate continuous flow during expiration in mandatory ventilation modes. (This is an enhancement, not a direct equivalence). |
| Method of Triggering | Flow or pressure (Servo 300); Volume (Babylog 8000) | Like Babylog 8000 (Volume triggering) where applicable, with flow triggering available for new modes (e.g., PSV). |
| O2 Concentration | 21 to 100 Vol% ±3 Vol% (both predicates) | Like Babylog 8000 (21 to 100 Vol% ±3 Vol%) |
| Pinsp | 10 to 120 cmH2O (Servo 300); 10 to 80 cmH2O (Babylog 8000) | 5 to 80 cmH2O (This range partially overlaps with both predicates, with enhanced lower limit compared to Babylog 8000 and a more restricted upper limit than Servo 300, but still within a clinically appropriate range for intended population). |
| PEEP | 0 to 50 cmH2O (Servo 300); 0 to 25 cmH2O (Babylog 8000) | Like Babylog 8000 (0 to 25 cmH2O) |
| Tidal Volume | Servo 300: adult: 2 to 4000 mL, pediatric: 0 to 400 mL, neonate: 0 to 40 mL. | |
| Babylog 8000: No (result of settings/system characteristics). | 2 to 100 mL (when VG option is activated). This is an enhancement providing volume control, which was not directly available on the Babylog 8000 but was available on the predicate Servo 300 for neonates (0 to 40 mL, the Babylog 8000 plus range includes and extends this). | |
| Alarm Functionality | Airway pressure, O2 concentration, Expired minute volume, Apnea, Gas supply, Power failure (common to both predicates). | Yes, for all common alarms. |
| Breathing frequency low/high: Yes (upper alarm limit only) - improved over both predicates (which had none). | ||
| Monitoring Parameters | Peak airway pressure, Mean airway pressure, PEEP, Expired tidal volume, Expired minute volume, Breathing frequency, FiO2, Supply pressures (common to both predicates). | Yes, for all common monitoring parameters. |
| New monitoring parameters: compliance, resistance, rate-volume-ratio (not on predicates). These are deemed "not essential for safety and effectiveness". | ||
| Physical Characteristics | Similar dimensions/weight, Gas supply pressure, Gas delivery system, Mains voltage range, Power consumption, Internal battery (where applicable to specific predicate). | Like Babylog 8000 for physical characteristics, gas supply, power supply (where comparable). Similar communication interface to predicates, medicament nebulizer capability. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or a clinical study with patients or patient data. This 510(k) summary focuses on demonstrating substantial equivalence through comparison of technological characteristics with predicate devices and adherence to technical standards. It is a "bench study" style comparison, implicitly relying on the design, function, and testing against standards rather than patient-specific performance data.
Therefore:
- Sample size for the test set: Not applicable (no test set of patient data described).
- Data provenance: Not applicable (no patient data described).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no test set with patient data is described, this section is not applicable. The assessment relies on engineering and regulatory experts to compare specifications and confirm adherence to standards. Dr. Klaus Freudenstein, Project Manager, is listed as having compared device performances, implying an engineering/technical background.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring ground truth adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for ventilation, not an AI or imaging diagnostic device. No human reader studies are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm, and its performance is assessed against established device characteristics and standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance and general clinical use, along with conformity to recognized technical standards (e.g., for ventilators). The comparison table on pages 2-3 serves as the primary evidence.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No AI model or training set is described.
Summary of the Study for Demonstrating Acceptance:
The "study" presented here is a comparison of the technological characteristics and intended use of the Dräger Babylog 8000 plus against two predicate devices: the Dräger Babylog 8000 (already marketed by the applicant) and the Siemens Servo 300.
The core of the study is a side-by-side tabular comparison (pages 2-3) of various features including:
- Control Principle
- Ventilation modes (CPAP, CMV, Assist Control, SIMV, PSV, VSV, PRVC, Manual inspiration, VG, VIVE)
- Ventilator settings (Tin, Tex, CMV rate, SIMV rate, I:E ratio, O2 concentration, Pinsp, PEEP, Insp. Flow, Tidal Volume, Minute Volume, Trigger sensitivity, Trigger response time, Rise time)
- Front panel controls and display technology
- Alarm functionalities (Airway pressure, O2 concentration, Expired minute volume, Apnea, Gas supply, Power failure, Breathing frequency, Battery supply, O2 cell disconnect, flow/pressure sensor errors, Ventilator inop)
- Monitoring Parameters (peak/mean airway pressure, PEEP, inspired/expired tidal volume, expired minute volume, spontaneous fraction of expired minute volume, percent leakage, breathing frequency, rate-volume-ratio, compliance, resistance, FiO2, supply pressures)
- Physical Characteristics (dimensions, weight, gas supply, power supply, internal battery)
- Special functions (communications interface, medicament nebulizer)
The study concludes that:
- The Babylog 8000 plus is an "enhanced version" of the Babylog 8000.
- New ventilation modes in the Babylog 8000 plus (not in Babylog 8000 software 3.0) are "substantially equivalent to ventilation modes of the Servo 300 ventilator of Siemens."
- Additional monitoring features (compliance, resistance, rate volume ratio) are provided, but are "not essential for the safety and effectiveness" concerning the intended use.
- The device "fulfills at least the same technical standards" as the predicate Dräger device and has been tested according to these standards.
- Therefore, the device is "as safe and effective as the predicate devices."
This is a regulatory submission study, not a clinical trial or performance study requiring patient data within this document. The "proof" is based on technical specifications, established standards, and a direct comparison to legally marketed predicate devices, demonstrating that the design and function are equivalent or superior without raising new questions of safety or effectiveness.
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(186 days)
DRAGER, INC.
Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.
Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater. Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.
This document is a 510(k) Pre-market Notification for the Dräger Babytherm 8004 / 8010 infant warmer system. The document claims substantial equivalence to several predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document presents a "Table of Comparison" which implicitly serves as the acceptance criteria by comparing the new device (Dräger Babytherm 8004 / 8010) against predicate devices (Babytherm 8000 WB, Radiant Heater RH 600, PT4000, and Microlite™). The "reported device performance" for the Dräger Babytherm 8004 / 8010 is listed within this table.
| Feature / Acceptance Criteria | Dräger Babytherm 8004 / 8010 Reported Performance | Equivalent Predicate Device | Notes/Differences |
|---|---|---|---|
| Intended Use | Infant warmer system providing warmth for premature and full-term neonates and infants up to 16 lbs. Use in delivery rooms, neonatal wards, NICUs. Optional phototherapy for Hyperbilirubinemia. | Babytherm 8000 WB, Radiant Heater RH 600, PT4000, Microlite™ | Combines functions of multiple predicate devices. |
| Physical Size | |||
| Height (mm) | 1820 to 2385 with height adjustment | Babytherm 8000 WB (1220 to 1515) | New device is taller. |
| Length (mm) | 1315 | Babytherm 8000 WB (1070) | New device is longer. |
| Width (mm) | Like Babytherm 8000 WB (750) | Babytherm 8000 WB (750) | Same. |
| Weight | 135 kg max | Babytherm 8000 WB (85 kg max) | New device is heavier. |
| Mattress Size (mm) | Like Babytherm 8000 WB (750 x 490) | Babytherm 8000 WB (750 x 490) | Same. |
| Bassinet Tilt | Like Babytherm 8000 WB (± 10° from horizontal) | Babytherm 8000 WB (± 10° from horizontal) | Same. |
| Case Material | Like Babytherm 8000 WB (PS-TSG) | Babytherm 8000 WB (PS-TSG) | Same. |
| Case Color | Like Babytherm 8000 WB (blue) | Babytherm 8000 WB (blue) | Same. |
| Power Input | |||
| Voltage | Like Babytherm 8000 WB (120 VAC, 60 Hz) | Babytherm 8000 WB (120 VAC, 60 Hz) | Same. |
| Total Power (W) | 670 W (8004) / 790 W (8010) + 120 W (height adjust) + 440 W (Phototherapy) | Babytherm 8000 WB (135 W + 560 W height adjust), RH 600 (735 W), PT4000 (120 W), Microlite™ (300 W) | Higher total power due to combined functionality. |
| Fuses | 2 x 15 A | Babytherm 8000 WB (2 x 1.6 A / 2 x 6.3 A), RH 600 (2 x 6.3 A), PT4000 (2 x 1.6 A), Microlite™ (2 x 4 A) | Higher fuse rating, likely due to increased power draw. |
| Leakage Current | 3, and heater output is reduced to level 2. | RH 600 (Actuates after 15 minutes in manual mode with level > 5) | Alarm condition modified based on IEC 601-2-21 requirements (trigger at >10 mW/cm²). |
| Visible Alarm | Yes | Babytherm 8000 WB, RH 600 | Same. |
| Audible Alarm | Yes | Babytherm 8000 WB, RH 600 | Same. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. It does not describe a clinical study with a test set, sample size, or data provenance in the way a clinical trial report would. The "testing" referred to is against international standards, not a specific patient cohort for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As this is not a study involving human interpretation or diagnostic accuracy, there is no "ground truth" established by experts in this context. The document relies on engineering specifications and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or human adjudication described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical apparatus (infant warmer), not a diagnostic or AI-powered system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context is the adherence to established international safety and performance standards (like IEC 601-2-21) and the functional specifications of predicate devices.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
Summary of the Study and Device Performance:
The "study" described in the 510(k) summary is not a traditional clinical trial but rather an engineering and regulatory comparison. The Dräger Babytherm 8004 / 8010 device demonstrates its "acceptance criteria" and "performance" by:
- Claiming Substantial Equivalence: The primary method is to show that the new device is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to several legally marketed predicate devices.
- Meeting International Standards: The document explicitly states that the Babytherm 8004 / 8010 "fulfill at least the same international standards as the predicate devices of Dräger and has been tested according to these standards" (e.g., IEC 601-2-21). This adherence to standards is the basis for demonstrating safety and effectiveness.
- Detailed Comparison Table: The provided "Table of Comparison" outlines various technical specifications and features, highlighting similarities and differences with predicate devices. Where differences exist (e.g., increased height, improved irradiance, wider temperature range, enhanced safety features), the document often explains these as "improved performance" or modifications to meet current standards.
In essence, the "study" is a regulatory submission that leverages an engineering comparison and compliance with established medical device standards to argue for the device's safety and effectiveness. It does not involve patient data collection or clinical outcomes in the manner of a clinical trial.
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(222 days)
DRAGER, INC.
Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg.
The device is microprocessor-controlled and provides the following ventilation modes :
- CMV - Intermittent Positive Pressure Ventilation Controlled and assisted volume-constant ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient's minute volume requirement.
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure and adjustable pressure support.
- PCV+ Pressure Controlled Ventilation Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level.
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
Furthermore Evita 2 dura offers the following special ventilation modes : - Apnea ventilation For switching over automatically to volume-controlled ventilation if breathing stops.
- ILV Independent Lung Ventilation, optional Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung.
Application range - Intensive care units
- Inner-clinical transport
The Evita 2 dura is a time cycled, constant volume ventilator for long term use in intensive care and inner clinical transport. The device is microprocessor controlled and provides the following ventilation modes:
- CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume contant ventilation with the options: - CPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
- SB Spontaneous Breathing Spontaneous breathing at ambient pressure
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure
- ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
- PCV+ Pressure Controlled Ventilation Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable
- Apnea Ventilation For switching over automatically to volume controlled mandatory ventilation if breathing stops
- ILV Independent Lung Ventilation Separate, differentiated, synchronized ventilation with one Evita 2 dura for each lung
The provided text is a 510(k) Summary for the Dräger Evita 2 dura ventilator, which claims substantial equivalence to predicate devices (Evita 4, Evita, and Servo 300). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing independent clinical studies with acceptance criteria in the way a novel therapeutic device might. Therefore, the document does not describe traditional acceptance criteria and a study proving the device meets them in the sense of performance metrics against a clinical ground truth.
Instead, the "acceptance criteria" here are implied by the comparison to predicate devices, showing that the Evita 2 dura operates within similar parameters and provides similar functionality. The "study" is this comparative analysis itself.
Here's an analysis based on the information provided, framed to address your questions as best as possible within the context of a 510(k) submission for substantial equivalence:
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a 510(k) for substantial equivalence, formal "acceptance criteria" with numerical targets are not explicitly stated in the document as they would be for a de novo device. The "acceptance criteria" are implicitly met if the device's characteristics are deemed substantially equivalent to the predicate devices. The performance is reported as a detailed comparison to these predicates.
Below is a summary table based on the provided comparison, highlighting key functional and technical specifications. The "Acceptance Criteria" column reflects what the device needs to match or be similar to in the predicate devices, and "Reported Device Performance" is the Evita 2 dura's characteristic.
| Feature | Implicit Acceptance Criteria (based on predicate Evita 4) | Evita 2 dura Reported Performance |
|---|---|---|
| Working Principle | Time cycled, volume constant, pressure controlled | Like Evita 4 (Time cycled, volume constant, pressure controlled) |
| Software Controlled | Yes | Yes |
| Gas delivery system | Fast "High Pressure Servo Valve", microprocessor controlled | Like Evita 4 |
| Ventilation Modes | CMV, SIMV, CPAP, ASB, Assist Control, MMV, PCV+ (BIPAP), APRV, CMV/Assist Control/SIMV/MMV with AutoFlow, ILV | All listed modes as Evita 4 |
| Rate (bpm) | 0.5 to 100 bpm | Like Evita 4 |
| Vt (Adult Mode) | 0.1 to 2.0 L | Like Evita 4 |
| O2-Conc. | 21 to 100 Vol.% | Like Evita 4 |
| Display Type | TFT-LC-Display (Color) | LC-Display (monochrom) or TFT (Color) |
| Alarm Condition Indicator | Red LED and TFT-LC-Display | Red LED and TFT or LC-Display |
| Audible Alarm | Yes, adjustable sound level | Yes, adjustable sound level |
| Power Supply (AC) | 100V to 240 V, 50/60 Hz | Like Evita 4 |
| CO2 / SpO2 Monitoring | Option for Evita 4 (built-in monitoring of expiration) | Option for Evita 2 dura (Evita 4 has this built-in) |
| DC Power Supply | Option, range 12 or 24V DC | Like Evita 4 |
2. Sample Size for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a clinical performance study with patient data. The "test" for substantial equivalence is primarily a comparison of technical specifications and functional features against legally marketed predicate devices.
- Sample Size: N/A (no clinical test set of patients or samples is described).
- Data Provenance: The data is a comparison of the technical specifications and features of the Dräger Evita 2 dura against three predicate devices: Dräger Evita 4, Dräger Evita, and Siemens Servo 300. This information would typically come from technical documentation, design specifications, and marketing materials of these established devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to a 510(k) submission based on substantial equivalence through technical comparison. There is no "ground truth" derived from expert consensus on a test set of medical data described in this document. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device(s).
4. Adjudication Method for the Test Set
- Not applicable, as there is no human adjudication of a clinical test set described. The "adjudication" is essentially the FDA's regulatory review of the substantial equivalence claim.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is typically for diagnostic imaging devices or other tools where human readers interpret results, and would not be relevant for a ventilator's functional equivalency claim.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a ventilator, which is a medical device directly interacting with a patient's respiratory system, not an algorithm providing a standalone diagnostic output. Therefore, an "algorithm-only" performance study as might be conducted for AI-based diagnostic software is not relevant here. The performance is assessed through hardware and software functionality and how it controls ventilation parameters.
7. Type of Ground Truth Used
- The "ground truth" in this context is the established safety and effectiveness of the predicate devices (Evita 4, Evita, and Servo 300), as demonstrated by their prior marketing clearance and use. The Evita 2 dura is deemed "substantially equivalent" if it shares similar technological characteristics and has the same intended use as these predicates, without raising new questions of safety or effectiveness.
8. Sample Size for the Training Set
- Not applicable. This document pertains to the market clearance of a medical device (ventilator) based on substantial equivalence, not the development or validation of a machine learning algorithm that requires a distinct training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a machine learning algorithm described.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a medical ventilator. The "acceptance criteria" and "study" are interpreted in the context of regulatory comparison to predicate devices, rather than a clinical trial with specific performance metrics and a patient-derived ground truth. The primary mechanism for clearance is showing that the new device is functionally and technologically similar to existing, legally marketed devices.
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(597 days)
DRAGER, INC.
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(226 days)
DRAGER, INC.
Not Found
Not Found
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The text is a summary and certification for a medical device (ventilator) and does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. It primarily lists administrative and classification information about the device.
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